Recalls / Class III
Class IIID-0631-2018
Product
Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05.
- Affected lot / code info
- Lot #: GW8264, HD3095, Exp 12/18
Why it was recalled
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Recalling firm
- Firm
- Sandoz Incorporated
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2555 W Midway Blvd, Broomfield, Colorado 80020-1632
Distribution
- Quantity
- 11,680 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2018-04-06
- FDA classified
- 2018-04-16
- Posted by FDA
- 2018-04-25
- Terminated
- 2019-04-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0631-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.